Biofrontera announces last patient enrolled in Phase 3 study of Ameluz-PDT

Biofrontera announces that patient enrollment is now complete in the Phase 3 clinical study evaluating Ameluz-PDT in combination with the BF-RhodoLED lamp for the treatment of basal cell carcinoma. This study is being conducted by Biofrontera Bioscience GmbH. This randomized, double-blind, placebo-controlled study aimed at enrolling 186 patients at 19 U.S. sites. With 183 patients now treated, and four more patients screened and awaiting histological results and treatment, the clinical sites have been informed that the enrollment is complete. Each patient had one or more clinically and histologically confirmed superficial BCC. Patients receive one cycle of two PDTs 1-2 weeks apart, which may be repeated after three months if required. The last assessment of the patient will take place three months after the final PDT cycle. The primary endpoint is the composite complete clinical and histological clearance of a main BCC lesion, which was selected at the beginning of the study. In addition, data on drug safety as well as secondary efficacy parameters of all BCCs will be evaluated. After completion of the trial, patients will be followed for an additional five years.